Mercè Boada, MD, PhD, Fundació ACE, International University of Catalonia, Barcelona, Spain, outlines the details of the Phase IIb/III randomized, placebo-controlled AMBAR study investigating the safety and efficacy of therapeutic plasma exchange (TPE) with albumin replacement in patients with mild/moderate Alzheimer’s disease. A total of 347 patients were randomized into four arms: one arm underwent a sham procedure and the other three arms received TPE with different replacement volumes of therapeutic albumin, with or without intravenous immunoglobulin. An initial 6-week intensive phase of weekly total plasma exchange was followed by a low volume exchange maintenance phase. At 14 months, Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL) scores showed 52% less decline in the treatment arms compared to placebo. Additionally, Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) scores showed a 66% reduction in decline compared to placebo. Global endpoints were assessed via the Clinical Dementia Rating Sum of Boxes (CDR-sb) and Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) scales. All patients treated with TPE showed statistically significant differences in these measures compared to placebo. This interview took place during the European Academy of Neurology 2021 congress.
Prof. Boada reports the following disclosures:
-Grants: La Caixa, Grifols, IMI, ISCII
-Advisory Board: Grifols, Araclon, Biogen, Roche, Lilly, Cortexyme
-Speaker honoraria: Biogen, Roche
-Consulting honoraria: Biogen, Roche, Merck, Cortexyme, Zambón